genomic-vision-scientist
4 November 2013Europe

A changing market: Genomic Vision's IP strategy

When the Supreme Court decided earlier this year that isolated genetic material is not patent-eligible, it opened up the genetic screening market, inevitably introducing a new battleground for asserting IP rights on diagnostic technologies.

Many companies, including Ambry Genetics and Gene by Gene, started offering their own tests that could identify genetic disorders and susceptibility to certain diseases immediately after the June 13 ruling, and a series of patent infringement cases were filed among the companies soon after, as each tried to muscle in to the market.

French biotechnology company Genomic Vision offers a novel method of genome analysis. Its proprietary technology, which it calls molecular combing, allows researchers to view the genome at a high resolution and identify genetic anomalies within it.

Molecular combing is the process of stretching, or ‘combing’ single DNA molecules on to glass slides, and finding genes or specific sequences in the genome by measuring the distances between markers, which can be seen by applying fluorescence hybridisation. Genomic Vision calls it “Genomic Morse Code”.

It was developed by Genomic Vision co-founder and chief executive Aaron Bensimon (pictured, left), who says that the method allows the team to see larger DNA rearrangements that drive disease, rearrangements that may not be detected by conventional gene sequencing methods.

Bensimon and his team discovered the molecular combing method in 1997, and later worked with French institutes involved with the Human Genome Project. The molecular combing method was used as a complementary tool in the effort, he says.

Disease function

“Genetic diseases are often characterised by two major mutations,” Bensimon explains. “The first and the most well-known is the point mutation, which are diseases characterised by one base pair mutation on the DNA.

“The second family of mutations is what we call large rearrangement. This is where larger pieces of DNA sequences have been deleted, added or rearranged in one manner or another.”

Large rearrangements are the drivers for cancers and genetic diseases such as facioscapulohumeral muscular dystrophy (FSHD), the second most common form of muscular dystrophy.

Bensimon says that conventional sequencing methods are more suited to finding these single base pair mutations on the genome, which means that large DNA rearrangements may not be spotted.

“Genomic Vision is developing diagnostic tests using our molecular combing technology adapted to those genetic diseases and cancer,” he says.

Patents and licensing

In July 2012, Genomic Vision announced the extension of its “Genomic Morse Code” patent portfolio, with the granting in several countries of the patent on a method of structural and visual analysis of the genome.

Its technologies are protected by a patent portfolio of eight families, which cover the process of the discovery, which were licensed by the Pasteur Institute, and the applications of molecular combing.

The patents also cover biomarkers and specific diagnostic tests involving large genome rearrangements.

“The institutes have a licence on the use of the combing technology and then we license them the specific application for the disease they will be interested in.”

Genomic Vision holds the exclusive world licence for molecular combing from the Pasteur Institute, and has strong ties with research institutes across Europe, collaborating with genomic research centre the Sanger Institute in the UK and cancer research hub the Curie Institute in Paris. It out-licenses process patents that cover the studies of cell cycle and DNA replication.

As part of its strategy it out-licenses patents owned by the Pasteur Institute, as well as patents from its own portfolio. “We are licensing our basic patent to use the technology,” Bensimon says.

“The institutes have a licence on the use of the combing technology and then we license them the specific application for the disease they will be interested in,” he explains.

Genomic Vision has also partnered with French biotech company Cellectis SA, which specialises in genome engineering, to pursue antiviral research. The effort is part of the ACTIVE project, which looks at how endonucleases, a type of enzyme, can be used to cure viral infections.

While Genomic Vision has its greater focus on R&D, in June 2013 it extended its strategic alliance agreement with US company Quest Diagnostics, which will commercialise its tests for the US market. Under terms of the agreement, Quest will invest in the development of a test for a hereditary genetic disease, and work with Genomic Vision to automate the testing process and speed up turnaround times for tests that use the molecular combing technology.

Genomic Vision entered the initial agreement with Quest in September 2010. It gave Quest exclusive rights in the US and other territories to develop and sell diagnostic tests based on the molecular combing technology, in return for an equity stake in the company and royalty fees.

Quest has developed its first test for FSHD, which Genomic Vision is currently commercialising in Europe. It is hoped that 500 to 700 patients a year will use the test, which is being routinely used at the La Timone medical centre in Marseille, and also being deployed as beta-test in Germany.

Now Genomic Vision is working on its own breast cancer test, but how has its work been affected by the conclusion of the Myriad case?

Myriad opportunities

“This year a lot of noise has been made around the breast cancer diagnostic test,” Bensimon says.

The Myriad case was widely publicised in specialist and popular media, creating controversy among research centres and civil liberties groups. Demand for the BRCA1 and BRCA2 breast cancer risk screens must also have received a boost when film star Angelina Jolie revealed she had undergone the test.

The final ruling on the case invalidated patents owned by Myriad that cover mutations in the BRCA1 and BRCA2 genes.

“The company has a commercial plan to expand further in Europe, and is working with hospitals in the UK and Switzerland.”

It wasn’t previously possible for Genomic Vision to commercialise its breast cancer tests in the US—“the market was closed” Bensimon says—but the end of Myriad’s monopoly brings opportunities for Genomic Vision, although it’s a crowded market with some significant competition. If anything is to keep Genomic Vision ahead of the field, it’s the company’s unique method.

Breast cancer can be triggered by a large DNA rearrangement, so Genomic Vision is developing a large rearrangement detection of the disease. He plans to commercialise the BRCA test in the US through Genomic Vision’s alliance with Quest, which last month announced its commercial strategy for the test.

The future of diagnosis

After commercialising tests for muscular dystrophy and breast cancer, Bensimon plans to create a screen for Lynch syndrome, a genetic condition that carries a high risk of colon cancer.

“Some of the colon cancers are characterised by different mutations on several genes, so we are developing a gene panel detection for Lynch syndrome,” Bensimon says.

Genomic Vision is also working on a test that will aim at detecting the human papillomavirus (HPV) integration in the genome of patient as a prognostic biomarker for cervical cancer. HPV has been estimated to be a factor in the development of cervical cancer in more than 90 percent of cases, more than 11,000 of which were reported in the US in 2010.

“It’s a huge market, and there’s a strong need for such a test,” Bensimon says. Genomic Vision is running a clinical trial on the test in French independent laboratory Alphabio.

The company has a commercial plan to expand further in Europe, and is working with hospitals in the UK and Switzerland.

In the near future, Bensimon hopes to see molecular combing becoming a complementary tool to next generation sequencing, and he predicts the technology will be used in hospitals as well as research institutes.

“Diagnostic tests using the molecular combing process will become indispensable to complement the diagnosis of current sequencing methods,” he says.